BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 2851474 · Received November 29, 2012

    Report

    Report Number
    2015691-2012-18725
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 7, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SINGLE DPT - VAMP PLUS KIT WAS RETURNED FOR EVALUATION. DRY BLOOD WAS VISIBLE AT THE DPT STOPCOCK, SAMPLE SITE AND PRESSURE TUBING CONNECTOR. THE PRESSURE TUBING WAS COMPLETELY DETACHED FROM THE SOLVENT BOND JOINT AT THE DISTAL SAMPLE SITE. INDICATIONS OF BONDING SOLVENT WERE PRESENT ONLY AT 1/3 OF THE BOND AREAS (TUBING AND SAMPLE SITE TUBE HOUSING). THERE WAS ALMOST NO BONDING SOLVENT AT THE OTHER 2/3 OF THE BOND AREAS OR SAMPLE SITE TUBE HOUSING. THE INNER AND OUTER DIAMETER OF THE TUBING WAS MEASURED AND FOUND WITHIN SPECIFICATION. THE COMPLAINT WAS CONFIRMED AND APPEARS TO BE RELATED TO INADEQUATE BONDING AT THE JOINT. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. AN INVESTIGATION IS OPEN TO DETERMINE THE ROOT CAUSE AND IMPLEMENT NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    AS REPORTED, THE PRESSURE TUBING DISCONNECTED FROM THE SAMPLING PORT OF THE VAMP SYSTEM. THE NURSE REPORTED THAT THE BABY "LOST A LOT OF BLOOD"; HOWEVER, NO TREATMENT OR TRANSFUSION WAS NEEDED, AND NO "RELEVANT CONSEQUENCES" WERE NOTED. THERE WAS NO ALARM FOR THE PRESSURE LOSS BECAUSE THE PROBLEM OCCURRED DURING TRANSPORT BETWEEN THE ICU AND TAC; AT THAT TIME THE PATIENT WAS MONITORED ONLY WITH ECG, SPO2 AND NIBP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFINED PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T001691A 59297028

    Patients

    Seq Age Sex Outcome Treatment
    1